Topic

Understanding What’s Changed in Medical Device Clinical Investigation Standards

Start Date

26 June 2026

End Date

26 June 2026

Start Time

10:00 AEST

End Time

11:30 AEST

Venue

ARCS Virtual Classroom

Who Can Register?

Anyone

New course!

Overview:

Stay ahead of the evolving regulatory landscape for medical device clinical investigations with this focused one-hour update session examining the key differences between ISO 14155:2020 and the recently published ISO 14155:2026 revision.

As global expectations for clinical evidence, participant safety, data integrity, and post-market oversight continue to evolve, understanding the practical implications of the updated standard will be essential for sponsors, CROs, clinical professionals, quality teams, and regulatory specialists working with medical devices.

Led by Suzanne Williams from Mobius Medical, this practical session will unpack the key changes, explore how these updates may impact clinical investigation design and execution, and help professionals update their systems, documentation, and operational approaches for compliance with the standard.

Whether you are currently managing device trials, overseeing quality systems, or preparing for regulatory submissions, this course will provide an efficient and practical overview of what matters most.

Why attend?

ISO 14155 remains the cornerstone standard for Good Clinical Practice (GCP) in medical device clinical investigations. Changes between versions can have significant implications for:

• Clinical investigation planning and governance
• Sponsor and investigator responsibilities
• Risk management integration
• Safety reporting expectations
• Documentation and quality systems
• Regulatory readiness across global markets

This course is designed to help participants quickly understand what is changing, why it matters, and what practical steps may be required.
 

Learning objectives: 

By the end of this session, participants will be able to:

• Understand the purpose and regulatory role of ISO 14155 in medical device clinical investigations
• Identify the updates in ISO 14155:2026
• Recognise updates that may affect sponsors, CROs, investigators, and ethics processes
• Explore implications for clinical investigation planning, conduct, and oversight
• Assess potential impacts on quality management systems and documentation
• Prepare for future implementation and compliance strategies

Who should attend: 

This course is ideal for professionals involved in medical device development, clinical investigations, and compliance, including:

• Clinical Research Associates (CRAs)
• Clinical Project Managers
• Regulatory Affairs Professionals
• Quality Assurance and GCP Professionals
• Medical Device Sponsors and Manufacturers
• CRO and Site Personnel
• Clinical Investigators and Research Coordinators
• Professionals transitioning into medical device clinical research

Speaker Information: Suzanne Williams, Mobius Medical

Suzanne Williams is a highly regarded medical device regulatory and clinical expert from Mobius Medical, with extensive experience supporting sponsors and organisations across clinical, regulatory, and quality frameworks. Suzanne brings practical sector insight and a strong understanding of evolving compliance expectations, helping professionals translate standards into real-world operational excellence.

Registration fees:

ARCS member - $90+ GST
Non-member - $125 +GST